Radiographic Evaluation of The Labial Bone Dimensional Changes After Immediate Implant

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Cairo University (CU)

Status

Completed

Conditions

Esthetic Zone
Immediate Implants
With Labial Grafting
Thin Labial Plate of Bone Pre-extraction
Without Labial Bone Grafting
Labial Bone Dimensional Changes

Treatments

Procedure: immediate implant placement without bone grafting
Procedure: immediate implant placement with socket bone grafting

Study type

Interventional

Funder types

Other

Identifiers

NCT05360693
IDCE.N1

Details and patient eligibility

About

For the dimension of the peri-implant buccal gap, a controversy is present whether complete bone formation labial to the implant. Therefore, leaving the blood clot in the large socket around implants without augmentation is questionable to result in complete bone fill and would not affect the buccal contour collapse. The aim of this clinical trial was to evaluate the labial bone dimensional changes after immediate implant placement in the esthetic zone with & without bone grafting inside the socket by using CBCT superimposition (Fusion) scans.

Enrollment

40 patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • adult (>20 years) with non-restorable maxillary teeth in the esthetic zone,
  • thick gingival phenotype,
  • intact but thin labial plate of bone (≤1mm)
  • intact palatal bone extending at least 6mm apically,
  • sufficient apical bone to attain implant primary stability (a minimum of 35 Ncm insertion torque)
  • labio-palatal socket dimension measured from the CBCT axial cut at mid-crestal part ≥5mm.
  • patients agreed to sign a written informed consent.

Exclusion criteria

  • smokers,
  • pregnant women,
  • patients with systemic disease,
  • patients with parafunctional habits such as bruxism or clenching,
  • infected socket,
  • periapical pathosis
  • history of radiotherapy or chemotherapy within the past 2 years.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

immediate implant placement without bone grafting
Experimental group
Description:
After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done 3-5mm into the bone apical to the socket according to the manufacturer's instructions. Patients will receive an immediate post-extraction implant without any grafting material in the socket between the residual labial bone and implant surface.
Treatment:
Procedure: immediate implant placement without bone grafting
immediate implant placement with bone grafting
Active Comparator group
Description:
After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done 3-5mm into the bone apical to the socket according to the manufacturer's instructions. Patients will receive an immediate post-extraction implant with placing bovine bone graft (Bio-oss) in the socket between the residual labial bone and implant surface.
Treatment:
Procedure: immediate implant placement with socket bone grafting

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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